Kornimate/medical-research-clean huggingface dataset:
safety and tolerability of once-daily oral aripiprazole in children and adolescents with tourette's disorder

Conditions: Tourette's Disorder; Tic Disorder

Summary: the goal of the current trial is to determine safety of once-daily aripiprazole in reducing total tic severity in children and adolescents with tourette's disorder.

tourette's disorder is a neuropsychiatric condition that is characterized by the appearance of tics that can be simple or complex in nature. a tic is a sudden, rapid, recurrent, non-rhythmic, stereotyped motor movement or vocalization. there are a very limited number of medications approved for the treatment of tourette's disorder. the goal of the current trial is to obtain additional efficacy, safety, and tolerability data in a controlled condition of a once-daily aripiprazole formulation in children and adolescents with tourette's disorder. the trial is a 52-week extension to the double-blind trial. the once-daily tablet formulation that will be evaluated in this trial represents a daily dosage regimen that is intended to be administered to children and adolescents.

Eligibility criteria:
inclusion criteria: * completed participation in trial 31-12-293 * written icf obtained from a legally acceptable representative \& informed assent at baseline as applicable by trial center's irb/iec * the subject, designated guardian(s) or caregiver(s) are able to comprehend and satisfactorily comply with the protocol requirements, as evaluated by the investigator exclusion criteria: * experienced aes during the double-blind trial (31-12-293) that would, in the investigator's judgment, preclude further exposure to aripiprazole. * the subject had protocol violations during the double-blind trial considered major in the judgment of the investigator which would deem the subject a poor candidate for the trial * a positive drug screen * sexually active patients not using 2 approved methods of contraception * females breastfeeding or pregnant (positive blood pregnancy test prior to receiving trial drug) * risk of committing suicide * body weight lower than 16 kg * abnormal laboratory test results, vital signs and ecg results

Keywords: tourette syndrome basal ganglia diseases brain diseases central nervous system diseases tic disorders tics movement disorders mental disorders aripiprazole
circulating and molecular markers involved in the processes of cachexia, anorexia and sarcopenia in patients with nsclc

Conditions: Non Small Cell Lung Cancer

Summary: the study aim to evaluate whether some substances produced by muscle or adipose tissue may play a role in the course of the disease by interfering with the effectiveness of therapies.

the study is aimed at patients with nsclc in whom plasma levels of particular biomarkers will be studied before and after treatment with chemotherapy and immunotherapy or immunotherapy alone. in particular, the plasma levels of gdf15, fgf21, hn, activin molecules and micrornas involved in inflammatory processes, called inflammamir, in particular of microrna146, 126, 21, 188, 155, will be studied. assessments of cellular markers of leukocyte aging will also be performed (determination of telomere length is a widely used measure of biological aging)

Eligibility criteria:
inclusion criteria: * patients with nsclc in advanced stage (iiib, iv) * patients eligible for the treatment with single-agent immunotherapy (pembrolizumab), or a chemo-immunotherapy combination among the approved ones for i line * obtainment of the informations related to medical history and the possibility to have an adequate follow up * obtainment of the informed consent * age ≥ 18 years exclusion criteria: * patients with psychiatric alterations, neurological diseases or other condistions that could not allow adhesion to study protocol and the obtainment of the icf

Keywords: non small cell lung cancer sarcopenia cachexia anorexia
study of testosterone and rhgh in fshd

Conditions: Facioscapulohumeral Muscular Dystrophy

Summary: the purpose of this study is to investigate the safety and tolerability of combination therapy with recombinant human growth hormone (rhgh) and testosterone in adult male patients with facioscapulohumeral muscular dystrophy (fshd) over 24 weeks.

this is a single-center, open-label study of daily human growth hormone (genotropin®, 5.0 μg/kg via subcutaneous injection) and testosterone (testosterone enanthate, 140mg via intramuscular injection every two weeks) for 24 weeks in men with fshd with a 12 week washout period. a total of 20 subjects will be enrolled at the university of rochester medical center in rochester, ny.

Eligibility criteria:
inclusion criteria: * a genetically confirmed diagnosis of fshd (or clinical symptoms suggestive of fshd with a first degree relative with genetically confirmed fshd) * hematocrit of ≤ 50% * prostate-specific antigen ≤ 4.0 ng/ml (or ≤ 3.0 ng/ml if the participant has a first-degree relative with prostate cancer) * fasting blood glucose \<126 mg/dl * able to walk continuously for six minutes (cane, walker, orthoses allowed) * able to independently administer intramuscular and subcutaneous injections (or have a family member who is capable and willing to administer these injections) exclusion criteria: * diabetes * obesity (bmi\>35 kg/m2) * cardiovascular disease (heart failure, coronary artery disease, uncontrolled hypertension, untreated hypercholesterolemia) * untreated thyroid disease * deep vein thrombosis * untreated severe sleep apnea * past pituitary disease * significant musculoskeletal injury and/or pain that affects walking * a systolic blood pressure over 160 or a diastolic pressure over 100 * plans to dramatically change exercise habits * liver disease * renal disease * cancer (other than basal cell skin cancer) * plans to conceive * heavy alcohol use (greater than 50g/day) * current testosterone or hgh use * current use of medications that interfere with the growth hormone or gonadal endocrine axis.
prevalence of sleep apnea and atrial fibrillation

Conditions: Sleep Apnea; Atrial Fibrillation

Summary: the investigators will screen consecutive patients presenting to the atrial fibrillation clinic for sleep apnea using a fda-approved home sleep testing device, watchpat to determine prevalence of sleep apnea in a clinic-based sample.

the investigators will determine the prevalence of sleep apnea among consecutive patients with atrial fibrillation (af) regardless of symptoms and determine the predictive value of screening tools for sleep apnea in this population. the primary outcome will be the prevalence of sleep apnea among all-comers with af. three secondary outcomes will be evaluated in the study. investigators will determine the efficiency and time-to-diagnosis of sleep apnea using a fda approved home sleep testing device (i.e. watchpat). these analyses will be compared to published studies performed using a traditional home sleep study test (which historically takes approximately 8-10 weeks). there will be no collection of data from a non-intervention group in our study. second, investigtaors will calculate the predictive value of traditional clinical screening tools in an af population using the stop-bang questionnaire and epworth sleepiness scale. third, investigators will identify potential risk factors for af in patients with sleep apnea using a logistic regression model.

Eligibility criteria:
inclusion criteria: * diagnosis of af confirmed on any electrocardiographic recording * age greater than or equal to 18 * ability to read and understand consent form, complete questionnaires, and provide informed consent exclusion criteria: * prior diagnosis of sleep disordered breathing or negative testing within the past 2 years without significant change in weight or clinical symptoms of sleep apnea * history of raynaud

Keywords: sleep apnea atrial fibrillation
tki followed by thoracic radiotherapy for stage iv egfr mutant nsclc

Conditions: Non-Small Cell Lung Cancer Metastatic

Summary: in this phase ii trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for egfr-mutant oligo-metastatic nsclc (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of tki therapy.

tyrosine kinase inhibitor (tki) has been widely accepted as the first-line therapy for stage iv nsclc with active mutation of egfr. olio-metastasis is a disease status between localized and extended status of disease, namely with the limited number of lesions, which is generally defined as ≤ 5. a couple of phase ii studies have shown that consolidation local management was able to prolong the local-regional tumor control and might further improve overall survival (os) for oligo-metastatic nsclc who have gained disease control from systemic therapy. however, there is lack of data regarding whether local radiotherapy (rt) could improve progression free survival (pfs) and os for nsclc with active egfr mutation who have benefited from tki. in this phase ii trial with single arm, we aim to investigate the clinical efficacy and toxicity profile of local radiotherapy on all disease sites for egfr-mutant oligo-metastatic nsclc (no more than 3 metastatic lesions) who did not experience disease progression after at least 3 months of tki therapy.

Eligibility criteria:
inclusion criteria: * age ≥18 and ≤75; * ecog performance status 0-1; * patients must provide study specific informed consent prior to study entry; * pathologically or cytologically diagnosed as nsclc; * egfr activating mutation to tki approved by histology, cytology or circulation tumor dna; * stage iv nsclc with ≤ 3 metastatic lesions (ajcc, 8th ed.) confirmed by meticulous radiographic examination. brain mri and 18f pet/ct is strongly recommended unless there is a contraindication; * patients have received≥3 months of tki therapy and do not received disease progression; * hb ≥ 10.0 g/dl; * absolute number of neutrophil granulocyte ≥ 1.5 × 109/l; * absolute number of plt ≥ 100 × 109/l; * total bilirubin ≤ 1.5 folds of the maximum extent; * alt and ast ≤ 2.0 folds of the maximum extent; * cr ≤ 1.25 folds of the maximum extent and ccr ≥ 60mll/min. exclusion criteria: * patients have received thoracic radiotherapy before; * malignant pleural effusion, pericardial effusion or peritoneal effusion; * patients have severe pulmonary comorbidity, such as ild, copd or other active pulmonary disease; * any unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, chf (nyha ≥ ii), mi within 6 months of enrollment, severe arrhythmia requiring medication，hepatic, nephric or metabolic disease; * hiv infection； * pregnancy or lactation women; * ecog status ≥2； * mixed sclc component; * other factors that is considered ineligible.

Keywords: non small cell lung cancer oligo-metastasis egfr activating mutation radiotherapy
efficacy of low dose sugammadex in reversal of nmb in laparoscopic barbaric surgery

Conditions: Bariatric Patients

Summary: the investigators aimed to compare the efficacy and safety of sugammadex at doses of 1.5, 2, and 4 mg/ kg for the reversal of moderate rocuronium-induced neuromuscular blockade in laparoscopic bariatric surgery.

patients were randomly assigned using a randomization-computer program into three groups according to the dose of sugammadex administrated (according to the ibw after t2 of tof): group i: patients were given 1.5 mg / kg. group ii: patients were given 2 mg / kg. group iii: patients were given 4 mg / kg.

Eligibility criteria:
inclusion criteria: * morbidly obese patients of both sex (bmi \> 40 kg.m-2) * scheduled for elective laparoscopic bariatric surgery (gastric bypass or sleeve surgery) under general anesthesia using rocuronium for tracheal intubation and maintenance of nmb * aged between 18 and 60 years and classified as asa ii - iii exclusion criteria: * liver and renal dysfunction, * disabling neuropsychiatric disorders, * history of stroke, brain trauma in the last 12 months * hypersensitivity to anesthetics, history of myocardial infarction, congestive heart failure * difficult tracheal intubation, and known or suspected disorder affecting nmb.
carotid artery stenting outcomes in the standard risk population for carotid endarterectomy

Conditions: Carotid Artery Disease; Stroke; Amaurosis Fugax; Transient Ischemic Attack (TIA)

Summary: the objective of the canopy trial is to assess the continued safety and effectiveness of the rx acculink carotid stent system under commercial use in subjects at standard risk for adverse events from carotid endarterectomy (cea) enrolled by physicians with a range of carotid stenting experience.


Eligibility criteria:
inclusion criteria: 1. subject must be ≥ 18 years of age. 2. subject does not have any condition that limits their anticipated survival to less than 3 years. 3. subject or a legally authorized representative must provide written informed consent prior to any trial related procedure. 4. subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - or- 5. subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram. 6. subject with all the following target vessel characteristics: 1. discrete lesion in internal carotid artery (ica) with or without involvement of the contiguous common carotid artery (cca). 2. vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery. 3. absence of excessive vessel tortuosity that would impede delivery of devices. 7. subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure. exclusion criteria: 1. subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (cea). 2. subject with hgb \ 1.5. 3. subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions. 4. subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such. 5. subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 6. pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.

Keywords: carotid stent carotid endarterectomy
defining the role of insulin resistance in 'idiopathic' dilated cardiomyopathy

Conditions: Dilated Cardiomyopathy

Summary: this study will investigate the effects of rosiglitazone, a medicine commonly used to treat type 2 diabetes, on the utilization of glucose by the heart in patients with heart failure which is not due to heart attacks. the primary purpose of the study is to determine whether treatment with an insulin-sensitizing medication will improve the heart's ability to metabolize glucose (sugar).

nondiabetic patients with nonischemic cardiomyopathy who are insulin-resistance or insulin-sensitive based on a fasting homeostasis model assessment (homa) value are eligible for the trial. at baseline, a 6-minute walk test is performed, followed by assessment of coronary flow reserve with ammonia-pet imaging before/after adenosine infusion. subjects are then given an oral glucose load (75g), followed by pet imaging with f-18-fluoro-2-deoxyglucose (fdg). subjects then begin taking rosiglitazone 4 mg qd x 12 weeks, after which the 6-minute walk test \& pet imaging is repeated.

Eligibility criteria:
inclusion criteria: * diagnosis of nonischemic dilated cardiomyopathy, current nyha class i-ii congestive heart failure * history of stage c-d heart failure with ef ≤ 40% during the course of the disease * treatment with a stable comprehensive heart failure regimen for at least 3 months (including beta-blockers and ace-inhibitors or angiotensin receptor blockers unless intolerant) * age \> 18 yrs exclusion criteria: * cardiomyopathy due to one of the following: * ischemic heart disease * primary valvular lesion * hypertrophic cardiomyopathy * cardiac resynchronization within the last 3 months * transaminase values \> 2.5 x upper limit of normal or history of liver disease * diagnosis of diabetes mellitus by: * diabetes previously diagnosed per patient history * 2 or more fasting glucose values \> 125 mg/dl * current nyha class iii or iv heart failure * serum creatinine \> 1.6 mg/dl * history of heart transplantation * pregnancy or active breast feeding * hospitalization for decompensated heart failure within 30 days prior to enrollment.

Keywords: nonischemic dilated cardiomyopathy
(cost-)effectiveness of mindfulness-based cognitive therapy (mbct) in cancer patients

Conditions: Distress; Anxiety; Depression

Summary: mindfulness-based cognitive therapy has been demonstrated to be effective in reducing anxiety, depression and fatigue in cancer patients. as this intervention can be offered in groups, costs are relatively low. in addition, delivering mbct online might make the intervention more accessible and cost-effectiveness. however, more information is needed about what treatment works best for which patient. therefore, the aim of this study is to investigate clinical and cost-effectiveness of both individual mbct online and mbct offered as a group training compared to tau . study design: the design of the study will be a multi-centre, randomised, superiority trial, comparing mbct online and mbct offered as a group training with tau. participants in the tau condition will be randomised to one of the treatment conditions after 3 months. main assessments will take place at baseline (t0), post-treatment (t1), and 3 (t2) and 9 months after post-treatment (t3). we expect the mbct conditions to be superior to tau in terms of improving mindfulness skills, anxiety and depressive compants, psychological well-being, rumination and fear of cancer recurrence. we also expect the mbct to result in patients returning to work earlier, have a higher work ability and have lower medical care costs, thereby being more cost-effective than tau.


Eligibility criteria:
inclusion criteria: * hads ≥ 11 * cancer diagnosis (at present or past) * stable dose if using psychopharmacological medication for at least 3 months * computer literacy and acces to internet * capable of filling out questionnaires in dutch exclusion criteria: * severe psychiatric morbidity as psychoses, suicidal ideation * previous mindfulness-based treatment.

Keywords: mindfulness mbct cancer oncology e-health cost-effectiveness
the effects of zn-containing granulate on patient morbidity and wound healing after free gingival graft surgery

Conditions: Surgery

Summary: there is no study in the literature showing the effects of zn on wound healing after free gingival graft (fgg) operation. the aim of this randomized clinical study was to compare the early healing results of the palatal wound after fgg harvesting by sterile hemostatic agent suturing or the use of surgical stent from thermoplastic zn-containing granules which was prepared chairside.

there are many studies reporting paresthesia, herpetic lesion, mucocele, excessive bleeding and severe postoperative pain after procedure.the highest pain level perceived in the palatal region after the fgg operation is experienced on the first day after the operation and decreases to the preoperative levels approximately 2 weeks after the operation. although hemostatics, bioactive substances, antibacterial and antiseptic agents, herbal effective products, platelet concentrations, low-dose laser applications, palatal stents are used in the palatal region to accelerate the healing stages and prevent such complications, an ideal support has not been found.

Eligibility criteria:
inclusion criteria: * periodontal and systemically healthy * ≥19 years old * amount of attached gingival width in the maxillary or mandibular anterior region \<2 mm * full mouth plaque index score, bleeding index score on full-mouth probing \<15% exclusion criteria; * previously undergone surgery for a graft harvested from the palate * presence of systemic disease * taking medication known to interfere with periodontal health * smoking

Keywords: free gingival graft surgery surgical stent zinc pain bleeding
effect of electromagnetic therapy on patients with chronic rhinosinusitis.

Conditions: Magnetic Therapy; Rhinosinusitis; Headache; Fatigue

Summary: this study aimed to evaluate the efficacy of pulsed electromagnetic field (pemf) for chronic sinusitis in a randomized, double-blind, placebo-controlled trial.

chronic sinusitis, or chronic rhinosinusitis, is an inflammatory condition defined by symptomatic inflammation of the paranasal sinuses lasting longer than 3 months. common presenting symptoms include nasal obstruction, facial pressure or fullness, nasal discharge (anterior or posterior), and olfactory loss. furthermore, chronic sinusitis is associated with reductions in patient quality of life, sleep quality, and daily productivity. a pulsed electromagnetic field (pemf) has an anti-inflammatory, antimicrobial, and improves the microcirculation of the mucosal membrane of the nasal cavity. it has been suggested that magnetic therapy can be used in treating chronic sinusitis but there is a scarce of studies about its usage.

Eligibility criteria:
inclusion criteria: * patients suffering from mild to moderate symptoms of rhinosinusitis. exclusion criteria: * pregnant or breastfeeding women. * patients with definite deviated nasal septum, sinusitis, or history of operation within the last 6 months. * patients with hypertension, diabetes mellitus, malignancy, active pulmonary tuberculosis, infection, active respiratory disease like asthma, or other systemic diseases. * patients with long-term use of corticosteroids or immunosuppressive agents. * patients who were involved in another clinical study within 30 days. * patients who were unable to comply with the follow-up schedules. * patients who had used antihistamines within 1 week, topical corticosteroids within 2 weeks, systemic corticosteroids within 4 weeks, anti-cholinergic drugs within 3 days, antileukotriene drugs within 1 week, decongestants within 3 days, tricyclic antidepressants or phenothiazines within 2 weeks, non-steroidal analgesics within 2 weeks, and other drugs which the researchers believed were inappropriate.